OneTouch Via On-Demand Insulin Delivery System

Pump, Infusion, Insulin Bolus

LifeScan Europe, A Division Of Cilag GmbH

The following data is part of a premarket notification filed by Lifescan Europe, A Division Of Cilag Gmbh with the FDA for Onetouch Via On-demand Insulin Delivery System.

Pre-market Notification Details

Device IDK163357
510k NumberK163357
Device Name:OneTouch Via On-Demand Insulin Delivery System
ClassificationPump, Infusion, Insulin Bolus
Applicant LifeScan Europe, A Division Of Cilag GmbH Gubelstrasse 34 Zug,  CH Ch-6300
ContactKirsten Franco
CorrespondentKirsten Franco
LifeScan Inc. 965 Chesterbrook Blvd Wayne,  PA  19087
Product CodeOPP  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-30
Decision Date2017-06-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00373108000037 K163357 000
00373108000020 K163357 000
00373108000006 K163357 000
00373108000013 K163357 000

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